Kornimate/medical-research-clean huggingface dataset:
oxidative stress and hemodialysis access failure

Conditions: End Stage Renal Disease; Hemodialysis

Summary: complications of hemodialysis access are the most frequent single reason for hospitalization among patients with end stage renal disease (esrd). uremia, and particularly uremia in patients with diabetes, is a state of increased oxidative stress. the central hypothesis to be tested by this project is that oxidative stress is a major (and modifiable) trigger for vascular access complications. we hope to slow or reduce rates of stenosis, thrombosis and access complications by giving vitamin e supplementation to patients being treated by hemodialysis.

patients continued their usual treatment on hemodialysis three times per week. this was a double-blinded placebo controlled trial. patients took either vitamin e 400 iu bid or placebo. an initial evaluation of access patency was performed and baseline blood drawn before starting vitamin e. every 3 months there was a followup evaluation with blood drawn for oxidative stress markers, and with a test of vascular access patency. the study was closed to new participants, vitamin e or placebo stopped, and data analysis performed in 2003.

Eligibility criteria:
inclusion criteria: adults, end stage renal disease treated by hemodialysis, patent hemodialysis vascular access (graft or fistula) exclusion criteria: temporary catheter dialysis access, inability to be compliant with study medication

Keywords: end stage renal disease treated by hemodialysis hemodialysis vascular access patency vitamin e oxidative markers pentosidine hydroxynonenal levuglandin
study of etoposide in breast cancer patients

Conditions: Breast Cancer

Summary: this study will examine how the body handles etoposide, a drug used to treat breast cancer. the knowledge gained may lead to more effective use of the drug with fewer side effects in the future. breast cancer patients who are receiving etoposide as part of their treatment may participate in this study. patients will have 18 blood samples (about a teaspoon or less each) drawn over a 72-hour period during and after their infusion of etoposide. the initial blood samples cannot be taken from the same intravenous line (small tube placed in a vein) used to deliver the etoposide, so a second line may have to be placed temporarily to obtain these samples.

etoposide is a topoisomerase ii inhibitor that has a broad range of anticancer activity at conventional doses (100 mg/m(2) daily x 5 days) and is administered in high doses (greater than 1200 mg/m(2)) as a component of pre-transplant myeloablative chemotherapy regimens. etoposide pharmacokinetics are linear over a 30-fold dose range, but disposition is highly variable. etoposide is highly protein bound (95%) to albumin, but protein binding (and therefore free drug concentrations) vary widely in cancer patients. etoposide is eliminated by metabolism and renal excretion, which may also contribute to the variability. the pharmacokinetics of etoposide will be studied in patients receiving high-dose etoposide as part of their pre-transplant preparative regimen, and pharmacokinetic parameters generated from pharmacokinetic modeling will be correlated with clinical and laboratory characteristics and toxicity in order to develop more rational dosing methods.

Eligibility criteria:
inclusion criteria age greater than or equal to 18 years. patients with breast cancer who are entered on existing medicine branch protocols that include high-dose etoposide. must be able to provide informed consent.

Keywords: etoposide breast cancer pharmacokinetics
supraclavicular versus interscalene block for shoulder surgery

Conditions: Pain

Summary: the purpose of this study is to compare the supraclavicular block to interscalene block in patients undergoing arthroscopic shoulder surgery.

the aim of this study is to evaluate the efficacy of the supraclavicular block in comparison with interscalene block on postoperative pain, quality of recovery and side effects in patients undergoing arthroscopic shoulder surgery under general anesthesia.

Eligibility criteria:
inclusion criteria: * patients undergoing shoulder surgery in american society of anesthesiologists physical status i-ii exclusion criteria: * with a known allergy to study medications, * chronic opioid use, * ipsilateral upper limb neurological deficits, * severe respiratory disease, * coagulopathy

Keywords: pain anesthesia recovery period brachial plexus
a study of ibi129 in subjects with unresectable, locally advanced or metastatic solid tumors

Conditions: Solid Tumor

Summary: this is a phase 1/2 multicenter, first-in-human study of ibi129. it includes a phase 1 dose escalation and expansion section to identify mtd/rp2d of ibi129, plan to enroll 22\~180 subjects, and a phase 2 to explore efficacy, safety and tolerability of ibi129 at rp2d in specified types of solid tumor. approximately 182 evaluable subjects will be enrolled for phase 2


Eligibility criteria:
inclusion criteria: 1. subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol; 2. at least 1 evaluable lesion according to response evaluation criteria in solid tumors (recist) version 1.1.; 3. male or female subjects ≥ 18 years old; 4. eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1; 5. anticipated life expectancy of ≥ 12 weeks; 6. adequate bone marrow and organ function exclusion criteria: 1. participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study; 2. received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter. 3. progressed refractory to an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase i inhibitor. 4. plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study; 5. known symptomatic central nervous system (cns) metastases.
optimum timing for surgery after pre-operative radiotherapy 6 vs 12 weeks

Conditions: Adenocarcinoma of the Rectum; Adenocarcinoma; Adenocarcinoma, Mucinous; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Summary: the aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 6 weeks. hypothesis: greater downstaging and tumour regression is observed when surgery is delayed to 12 weeks after completion of crt compared to 6 weeks.


Eligibility criteria:
inclusion criteria: * aged \> 18 * informed written consent * histological confirmation of adenocarcinoma of rectum * undergoing pre-operative radiotherapy/ chemotherapy * completion of pre-operative treatment exclusion criteria: * aged \< 18 * absence of pre-operative rt/ct * medical/ psychiatric conditions that compromise the patients ability to give informed consent * contra-indications to mri, i.e. hip prothesis, cardiac pacemaker

Keywords: rectal cancer 6vs12 6 vs 12 cancer crm circumferential resection margin quality of life mri radiology abdominoperineal excision anterior resection surgery pathology radiotherapy
safety of lumiracoxib in patients with osteoarthritis

Conditions: Osteoarthritis

Summary: this safety study evaluated the incidence of gastrointestinal adverse events and edema in patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator


Eligibility criteria:
inclusion criteria: * age \>=50 years old * primary osteoarthritis in hip, hand, knee or spine for at least 3 month * pain in the target joint of moderate intensity * written informed consent exclusion criteria: * secondary osteoarthritis * active upper gastro intestinal tract ulceration * inflammatory joint disease * gout * clinically significant hepatic or renal disease other in and exclusion criteria may apply

Keywords: osteoarthritis lumiracoxib rofecoxib cox-2 osteoarthritis (primary osteoarthritis hip, hand, knee or spine (cervical or lumbar)
the effectiveness of group-delivered guided written exposure therapy for ptsd and subclinical ptsd among adolescents : a pilot study

Conditions: PTSD

Summary: the study aims to examine the effectiveness of the group-delivered guided written exposure therapy (g-wet) for post-traumatic stress disorder (ptsd) and subclinical ptsd among chinese adolescents with a randomized controlled trial. the study will recruit 40 participants, with 20 randomized to the g-wet group and 20 randomized to the waiting list (wl) group. the g-wet intervention consists of 5-8 group sessions. the primary outcome pcl-5 ( ptsd checklist-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up assessments.


Eligibility criteria:
inclusion criteria: 1. adolescents aged 10-18 years. 2. meeting full or subthreshold ptsd (up to one symptom missing) diagnostic criteria according to the child ptsd symptom scale-interview version for dsm-5 (cpss-5-i). 3. if taking psychotropic medication, currently stabilized on psychotropic medication for at least four weeks. 4. capable of writing and understanding written instructions. exclusion criteria: 1. presence of severe psychopathology necessitating immediate medical attention 2. moderate to high suicide risk (e.g., intent or plan to attempt suicide in the near future) 3. evidence of a moderate or severe traumatic brain injury 4. currently undergoing psychotherapy specifically for ptsd.

Keywords: ptsd adolescents randomized controlled trial
daptomycin or vancomycin in treating bacteria in the blood in patients with neutropenia caused by chemotherapy

Conditions: Infection; Neutropenia; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

Summary: rationale: antibiotics, such as daptomycin and vancomycin, may be effective in treating bacteria in the blood. it is not yet known whether daptomycin is more effective than vancomycin in treating bacteria in the blood in patients with neutropenia caused by chemotherapy. purpose: this randomized clinical trial is studying daptomycin to see how well it works compared with vancomycin in treating bacteria in the blood in patients with neutropenia caused by chemotherapy.

objectives: primary * compare the safety of daptomycin vs vancomycin in cancer patients with chemotherapy-induced neutropenia and gram-positive bacteremia. * compare the efficacy of these drugs, in terms of fever resolution, bacteremia resolution, inflammation indicators reduction, implanted catheter salvage, and reduced need for antifungal therapy, in these patients. outline: this is an open-label, randomized, pilot study. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive daptomycin iv over 30 minutes once daily. * arm ii: patients receive vancomycin iv over 60 minutes twice daily. treatment in both arms continues for approximately 7-14 days or until microbiologic failure, unsatisfactory clinical (symptomatic) response, or fever and neutropenia is resolved (absolute neutrophil count ≥ 1,000/mm\^3 on ≥ 2 consecutive days). patients may be removed from the study if the isolate is found to be sensitive to the original antibiotics or resistant to either of the study drugs. after completion of study therapy, patients are followed at 6 and 12 weeks. projected accrual: a total of 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of a malignancy * chemotherapy-induced neutropenia (absolute neutrophil count \< 500/mm\^3) * two or more blood cultures positive for gram-positive cocci * at least 0.2 colony-forming units/ml on lysis-centrifugation culture * currently receiving broad-spectrum antimicrobial therapy appropriate for febrile neutropenia * no meningitis, endocarditis, osteomyelitis, or pneumonia (by clinical or radiologic criteria) patient characteristics: * life expectancy ≥ 7 days * no allergy or intolerance to vancomycin or daptomycin * creatinine clearance ≥ 30 ml/min * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for at least 30 days after completion of study treatment * no underlying myopathy or neurologic disease (e.g., guillan-barre or multiple sclerosis) prior concurrent therapy: * see disease characteristics * no concurrent hmg coa reductase inhibitors (statins) * no concurrent gemfibrozil or clofibrate

Keywords: unspecified adult solid tumor, protocol specific infection neutropenia unspecified childhood solid tumor, protocol specific
comparison of cabg related bleeding complications in patients treated with ticagrelor or clopidogrel

Conditions: Blood Loss, Surgical; Ticagrelor; Clopidogrel

Summary: in patients with coronary artery disease, dual antiplatelet therapy (acetylsalicylic acid and a p2y12-receptor antagonist) is a commonly used method because of its excellent antithrombotic effect. in particular, in patients with acute myocardial infarction, who receive coronary angiography as an emergency, the dual antiplatelet is used immediately before the test to prevent and test further clot formation, regardless of whether or not the patient had previously taken dual antiplatelet. ticagrelor, a direct-acting and reversible adp receptor antagonist, was introduced in denmark in 2013 and is now the most commonly used adp receptor antagonist in the treatment of acs. compared to its predecessor clopidogrel, the pharmacokinetic proﬁl of ticagrelor is more predictable, demonstrating a faster onset of action and a more consistent platelet inhibition. however, because of the excellent antithrombotic effect and increased bleeding potential, it is recommended that major bleeding, such as opcab or cabg surgery, be expected with a high probability, and in case of fatal surgery, the drug should be discontinued for 5 days. most patients who receive emergency coronary heart surgery after undergoing coronary angiography as an emergency due to an acute myocardial infarction, it take approximately 24-48 hours to undergo surgery after examination. in fact, there have been reports of large-scale cross-country studies that do not increase bleeding risk compared to 5 days until 3 days after ticagrelor is stopped. therefore, this study aimed to retrospectively analyze the bleeding tendency by analyzing the records of patients using clopidogrel or ticagrelor in preoperative coronary angiography for patients undergoing emergency cabg surgery from 2016 to september 2019.


Eligibility criteria:
inclusion criteria: * the patient with acute myocardial infarction received loading dose of clopidogrel or ticagrelor for coronary angiography within 2 days prior to emergency opcab or cabg. exclusion criteria: * heart surgery combined with other operation (valve surgery, aorta surgery, trauma surgery) * history of coagulopathy * history of liver cirrhosis
therapeutic effects of cryotherapy on arthrogenic muscle inhibition in patients with cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Injury

Summary: anterior cruciate ligament(acl) injury is one of the most common sport injuries. the major problem after acl reconstruction or rehabilitation program is quadriceps weakness. previous studies suggested that cryotherapy and transcutaneous electrical nerve stimulation(tens) can effectively reduce the arthrogenic muscle inhibition caused by experimental swelling. objective: to exam the effects of 12 weeks cryotherapy and tens on arthrogenic muscle inhibition in subjects with acl reconstruction. design: prospective study. subjects: male subjects with isolated acl injury, age between 18\~40 years old are going to receive an acl reconstruction surgery. methods: quadriceps activation level, quadriceps peak torque during maximal voluntary contraction and rate of force development are measure at presurgery, 3-month, 6-month after surgery. after surgery, subjects will receive 12 weeks, 3 days/week, training programs included 20 minutes cryotherapy and exercise training with tens. data analysis: data will be analyzed using spss 13.0 software (spss inc., chicago, il). one-way anova will be used to analysis data.

examination procedure: 1. skin preparation and emg setting. 2. fill out knee joint function questionnaire. 3. warmup with a stationary bike. 4. single hop for distance. 5. mvic test and emg recording. 6. endurance test. 7. record surface emg of vastus lateralis, vastus medialis, biceps femoris and semitendinosus during maximal voluntary contraction.

Eligibility criteria:
inclusion criteria: * male subjects with isolated acl injury, age between 18\~40 years old are going to receive an acl reconstruction surgery. exclusion criteria: * meniscus lesion, bony fracture and osteochondral lesions

Keywords: muscle activation acl reconstruction cryotherapy tens
manual therapy effectivity and exercises in musicians

Conditions: Orofacial Pain

Summary: orofacial pain is one of the most common dysfunctions among wind musicians, a population with a high incidence of temporomandibular disorder (tmd). regarding the treatment of tmd, the efficacy of manual therapy and therapeutic exercise has been studied, but there is a lack of high quality research supporting its implementation. there is, however, an agreement on the need of combining the treatment of the temporomandibular joint and the cervical spine, due to their close biomechanical relation. aims of the study: to analyse the efficacy of an evidence-based manual therapy protocol alone or in combination with an exercise program on the treatment of orofacial pain during musical practice on wind musicians. furthermore, this study aims at observing whether if said treatment is more effective in the short, medium, or long term, and which variables are the most influenced.

methods: a sample of 40 wind musicians with orofacial pain during practice with the instrument will be recruited in the different conservatories of the community of madrid. the sample will be divided into two different groups: a control group who will receive the manual therapy protocol, and an experimental group who will, in addition, receive an exercise program. treatment will consist of ten session distributed along 5 weeks, of an approximated duration of 30 minutes per session. assessments will be carried out pre- and post-intervention, and for a two- and four-months follow-up.

Eligibility criteria:
inclusion criteria: * metal or wood wind musicians * orofacial pain during the practice in the last 30 days. * more than 20 hours by week in the practice. * between 18-65 years old. exclusion criteria: * neurological diseases. * analgesics previous treatments. * any trauma or bone fractures in skull or cervical spine. * any surgical intervention in cervical spine, orofacial region or temporo-mandibular joint.

Keywords: orofacial pain wind musicians manual therapy exercise program
conversion therapy of sintilimab in combination with apatinib and chemotherapy in stage iv gastric cancer

Conditions: Gastric Cancer Stage IV

Summary: this is a single-arm, phase ii study aiming to evaluate the feasibility and efficacy of sintilimab (pd-1 inhibitor) in combination of apatinib and two-drug chemotherapy (s-1 plus nab-paclitaxel) as conversion therapy in patients with stage iv gastric cancer in china.


Eligibility criteria:
inclusion criteria: * gastric adenocarcinoma confirmed by gastroscopy and pathology (histologically/cytologically ) ; * life expectancy of ≥3-month； * unresectable patients who were initially diagnosed as stage iv (clinical stage, american joint committee on cancer 8th edition); * eastern cooperative oncology group performance status: 0-1; * must have at least 1 of the following unresectable factors indicated by ct, mri or positron emission tomography(pet)-ct: 1. n3 lymphatic metastasis; 2. extensive or bulky lymph nodes; 3. t4b; 4. hepatic metastasis: ≤5 lesions, total diameter of ≤8cm; 5. peritoneal metastasis (cy1, p1); 6. kukernburg tumor; * adequate organ function; * pregnant test negative of females of childbearing potential , and willing to use adequate contraception; * written informed consensus form; exclusion criteria: * prior use of any checkpoint inhibitor treatment, including pd-1, programmed cell death ligand-1(pdl-1), ctla4 etc; * her-2 positive with willing to use herceptin treatment; * prior active autoimmune disease or history of autoimmune disease; * clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, congestive heart failure (new york heart association (nyha) class \> 2), ventricular arrhythmia which need medical intervention, left ventricular ejection fraction(lvef) \< 50%; * not controlled hypertension; * prior systemic treatment to metastatic disease； * previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency; * history of immunodeficiency including seropositivity for human immunodeficiency virus (hiv), or other acquired or congenital immune-deficient disease, or active hepatitis ; * patients who may receive vaccination during study period; * mental disorders history, or psychotropic drug abuse history; * unable to orally administration;

Keywords: pd-1 inhibitor conversion therapy
pulmonary rehabilitation for copd patients: can performance predict exacerbation?

Conditions: COPD; COPD Exacerbation; Pulmonary Rehabilitation

Summary: the aim of pulmonary rehabilitation is to improve exercise capacity and reduce dyspnoea. as well as improving the patient's overall condition, pulmonary rehabilitation provides a means to monitor the patient regularly. during physical exercise, the increased activity of the muscle system increases cardiac and respiratory output. if the patient's respiratory status deteriorates, as occurs, for example, before the onset of an exacerbation, exercise capacity could be reasonably expected to reduce. the investigators hypothesised, therefore, that changes in the physical capacity of patients with copd during a rehabilitation session could provide a predictive indication regarding the risk of occurrence of exacerbation.


Eligibility criteria:
inclusion criteria: * adult patients * copd patients exclusion criteria: * patients who not performed not at least 5 sessions of the pulmonary rehabilitation program * occurence of an adverse event that prevents further rehabilitation * exacerbation in the previous month